Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

Summary

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Timeline

Start

2005-07

Primary completion

—

Completion

2005-08

Drugs

Indications